RA Sr. Manager - Associate Director @ Global Startup Biopharma

Tokyo 23 Wards Permanent ¥17,000,000 - ¥20,000,000 Foreign Multinational
  • Be part of a fast growing, exciting new global biopharma starting up in Japan
  • Take lead in regulatory strategy and development for regulatory approval

About Our Client

  • Global Bio pharmaceutical company starting up globally and now here in Japan
  • Rich pipeline with over 10 assets already in processes in Japan
  • Primarily focusing on Oncology as well as various other therapeutic areas for unmet medical needs
  • Blue-chip financial backing with high growth potential
  • Dynamic start-up environment with a focus on progressive innovation and diversity

Job Description

  • Develop RA strategies and development for products to obtain approval
  • Take lead in communication as well as negotiation with PMDA consultation
  • Work with global stakeholders as well as cross functioning departments to align local and global objectives
  • Develop key essential documentations ex. CTN application, NDA submission and other approvals
  • Ensure proper regulatory compliance as well as facilitating review with new regulatory developments
  • Develop the regulatory department from the ground up

The Successful Applicant

  • University degree in pharmacy, biology, or scientific field
  • Experience in regulatory submissions and approval or took part in a pharmaceutical regulatory authority facing responsibility
  • Deep understanding of regulatory guidelines and other requirements
  • Experience in people management
  • High fluency in English and Japanese (Non-native level speakers will not be selected)
  • Understanding of GxP

What's on Offer

  • Top of the market salary and compensation
  • Start-up international environment
  • Great work life balance
  • Amazing career progression in regulatory affairs
  • Work with industry individuals solving unmet medical demands
  • Opportunity to build the RA department from the ground up
  • Be a key influence and decision maker in the organisation
Zach Itozu
Quote job ref
Phone number
+813 6832 8683

Job summary

What is your area of specialisation?
Healthcare / Pharmaceutical
Tokyo 23 Wards
Job Type
Consultant name
Zach Itozu
Consultant phone
+813 6832 8683
Job Reference
Company Type
Foreign Multinational